Study of Multiple Doses of Saxagliptin (BMS-477118) | NCT00950599 | Trialant
NCT00950599
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Apr 3, 2015Estimated
Enrollment
423Actual
Phase
Phase 2
Conditions
Type 2 Diabetes Mellitus
Interventions
Saxagliptin
Saxagliptin
Saxagliptin
Saxagliptin
Saxagliptin
Saxagliptin
Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00950599
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CV181-008
Secondary IDs
Not provided
Brief Title
Study of Multiple Doses of Saxagliptin (BMS-477118)
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-477118 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Mar 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2003
Primary Completion Date
May 2004Actual
Completion Date
May 2004Actual
First Submitted Date
Jul 31, 2009
First Submission Date that Met QC Criteria
Jul 31, 2009
First Posted Date
Aug 3, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 28, 2009
Results First Submitted that Met QC Criteria
Feb 4, 2010
Results First Posted Date
Feb 23, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 16, 2015
Last Update Posted Date
Apr 3, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
423Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Saxagliptin (2.5 mg)
Experimental
Drug: Saxagliptin
Saxagliptin (5 mg)
Experimental
Drug: Saxagliptin
Saxagliptin (10 mg)
Experimental
Drug: Saxagliptin
Saxagliptin (20 mg)
Experimental
Drug: Saxagliptin
Saxagliptin (40 mg)
Experimental
Drug: Saxagliptin
Saxagliptin (100 mg)
Experimental
Drug: Saxagliptin
Placebo
Placebo Comparator
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Saxagliptin
Drug
Tablets, Oral, 2.5 mg, once daily, 12 weeks
Saxagliptin (2.5 mg)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort
Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.
Baseline, Week 12
Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes who are drug-naive
Screening HbA1c ≥ 6.8% and ≤ 9.7%
Screening fasting or random C-peptide > 0.5 ng/mL
< 35 years old must be negative for anti-GAD antibodies
Body Mass Index < 35 kg/m2
Exclusion Criteria:
Symptoms of poorly controlled diabetes
History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening
Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis
Rosenstock J, Sankoh S, List JF. Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2 diabetes. Diabetes Obes Metab. 2008 May;10(5):376-86. doi: 10.1111/j.1463-1326.2008.00876.x. Epub 2008 Mar 18.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
FG001
Saxagliptin 5 mg (0-40 mg Cohort)
The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
FG002
Saxagliptin 10 mg (0-40 mg Cohort)
The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
FG003
Saxagliptin 20 mg (0-40 mg Cohort)
The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
FG004
Saxagliptin 40 mg (0-40 mg Cohort)
The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
FG005
Placebo (0-40 mg Cohort)
The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
FG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
FG007
Placebo (0 & 100 mg Cohort)
The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
FG008
Saxa 0-40 mg Cohort (Follow-up Period)
The follow-up period is 4 weeks and includes: subjects completing 12 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
FG009
Saxa 0 & 100 mg Cohort (Follow-up Period)
The follow-up period is 4 weeks and includes: subjects completing 6 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
Periods
Title
Milestones
Reasons Not Completed
Double-Blind Treatment Period
Type
Comment
Milestone Data
STARTED
FG00055 subjects
FG00147 subjects
FG00263 subjects
FG00354 subjects
FG004
COMPLETED
FG00048 subjectsCompleted 12 weeks of treatment
FG00137 subjectsCompleted 12 weeks of treatment
FG00254 subjectsCompleted 12 weeks of treatment
FG003
NOT COMPLETED
FG0007 subjects
FG00110 subjects
FG0029 subjects
FG00311 subjects
FG004
Type
Comment
Reasons
Administrative reason by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Follow-Up Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
BG001
Saxagliptin 5 mg (0-40 mg Cohort)
BG002
Saxagliptin 10 mg (0-40 mg Cohort)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort
Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.
Randomized participants. To be included in analysis of positive efficacy trend in change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Deviation
percentage of glycosylated hemoglobins
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Saxagliptin 10 mg (0-40 mg Cohort)
The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal.
Baseline, Week 6
Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Baseline, Week 12
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Baseline, Week 6
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Baseline, Week 12
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Baseline, Week 6
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Baseline, Week 12
Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort
Baseline, Week 12
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Baseline, Week 6
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Baseline, Week 12
Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Baseline, Week 6
Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Baseline, Week 12
Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.
Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Baseline, Week 6
Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Baseline, Week 12
Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Baseline, Week 6
Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Baseline, Week 12
Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Baseline, Week 14
Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Baseline, Week 10, Week 16
Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Baseline, Week 8, Week 14
Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Baseline, Week 10, Week 16
Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Baseline, Week 8, Week 14
Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Baseline, Week 10, Week 16
Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C <7%, ≥7% to <8%, ≥8% to <9%, and ≥9% in the 0 & 100 mg cohort.
Baseline, Week 6
Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG <140 mg/dL, ≥140 mg/dL to <180 mg/dL, and ≥ 180 mg/dL in the 0 & 100 mg cohort.
Baseline, Week 6
Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort
Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose <140 mg/dL, ≥140 to <200 mg/dL, and ≥200 mg/dL in the 0 & 100 mg cohort.
Baseline, Week 6
Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort
Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort.
Week 6
Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort
Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)
Baseline, Week 6
Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort
Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)
Baseline, Week 6
Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control
Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.)
Week 4, Week 6
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations
52 subjects
FG00567 subjects
FG00644 subjects
FG00741 subjects
FG0080 subjects
FG0090 subjects
43 subjects
Completed 12 weeks of treatment
FG00445 subjectsCompleted 12 weeks of treatment
FG00555 subjectsCompleted 12 weeks of treatment
FG00644 subjectsCompleted 12 weeks of treatment
FG00735 subjectsCompleted 12 weeks of treatment
FG0080 subjects
FG0090 subjects
7 subjects
FG00512 subjects
FG0060 subjects
FG0076 subjects
FG0080 subjects
FG0090 subjects
1 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Lack of Efficacy
FG0002 subjects
FG0015 subjects
FG0025 subjects
FG0037 subjects
FG0043 subjects
FG0056 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0052 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
Poor/Noncompliance
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
Subject no longer meets study criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Subject Withdrew consent
FG0004 subjects
FG0013 subjects
FG0023 subjects
FG0031 subjects
FG0041 subjects
FG0052 subjects
FG0060 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008309 subjectsthose completing double blind period (DB) + those rescued/discontinued from DB due to hyperglycemia
FG00980 subjectsthose completing double blind period (DB) + those rescued/discontinued from DB due to hyperglycemia
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008296 subjects
FG00978 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00813 subjects
FG0092 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Poor/Noncompliance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
BG003
Saxagliptin 20 mg (0-40 mg Cohort)
BG004
Saxagliptin 40 mg (0-40 mg Cohort)
BG005
Placebo (0-40 mg Cohort)
BG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
BG007
Placebo (0 & 100 mg Cohort)
BG008
Total
Total of all reporting groups
55
BG00147
BG00263
BG00354
BG00452
BG00567
BG00644
BG00741
BG008423
participants
Title
Denominators
Categories
<65 years
Title
Measurements
BG00050
BG00139
BG00254
BG00350
BG00441
BG00555
BG00638
BG00735
BG008362
>= 65 years
Title
Measurements
BG0005
BG0018
BG0029
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00033
BG00122
BG00223
BG00316
BG00422
BG00525
BG00617
BG00718
BG008176
Male
BG00022
BG00125
BG00240
BG00338
BG004
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00051
OG00142
OG00260
OG00351
OG00450
OG00562
Title
Denominators
Categories
Title
Measurements
OG000-0.67± 0.80
OG001-0.95± 0.97
OG002-0.81± 0.91
OG003-0.74± 0.93
OG004-0.78± 1.04
OG005-0.29± 0.82
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
A test for log-linear trend across saxagliptin doses was performed using a linear contrast among the saxagliptin doses from an analysis of covariance (ANCOVA) model. The ANCOVA model was the same model used for the first secondary endpoint.
Kruskal-Wallis
ANCOVA Model: post-pre=pre treatment.
0.9888
A significance level of alpha = 0.05 was used for the trend test.
95
No
Superiority or Other
Primary
Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort.
95
No
Superiority or Other
Secondary
Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
percentage of glycosylated hemoglobins
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00045
OG00140
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.71± 0.09
OG001-0.72± 0.10
OG002-0.67± 0.09
OG003
Secondary
Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00050
OG00146
OG00261
OG003
Title
Denominators
Categories
Title
Measurements
OG000-10.71± 3.68
OG001-18.63± 3.82
OG002-16.10± 3.32
OG003
Secondary
Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00050
OG00146
OG00261
OG003
Title
Denominators
Categories
Title
Measurements
OG000-10.85± 4.61
OG001-21.68± 4.80
OG002-15.91± 4.16
OG003
Secondary
Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
umol/L
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00053
OG00144
OG00261
OG003
Title
Denominators
Categories
Title
Measurements
OG000-21.02± 3.91
OG001-21.87± 4.29
OG002-24.72± 3.65
OG003
Secondary
Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
umol/L
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00054
OG00144
OG00261
OG003
Title
Denominators
Categories
Title
Measurements
OG000-20.89± 4.64
OG001-25.23± 5.14
OG002-21.31± 4.36
OG003
Secondary
Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0, 100 mg Cohort)
OG007
Placebo (0, 100 mg Cohort)
Units
Counts
Participants
OG00045
OG00142
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.88± 1.22
OG0011.05± 1.26
OG002-0.99± 1.11
OG003
Secondary
Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00042
OG00130
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.38± 1.63
OG0011.02± 1.93
OG0021.41± 1.54
OG003
Secondary
Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00045
OG00142
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.15± 0.12
OG001-0.19± 0.13
OG002-0.06± 0.11
OG003
Secondary
Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00042
OG00130
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.04± 0.14
OG001-0.13± 0.16
OG002-0.09± 0.13
OG003
Secondary
Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg*min/dL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00046
OG00137
OG00255
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1226± 318
OG001-1503± 353
OG002-1312± 290
OG003
Secondary
Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg*min/dL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00039
OG00129
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1121± 320
OG001-1505± 369
OG002-1730± 289
OG003
Secondary
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU*min/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00044
OG00137
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG000234.2± 149.5
OG001293.2± 162.3
OG002120.0± 136.6
OG003
Secondary
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU*min/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00039
OG00126
OG00246
OG003
Title
Denominators
Categories
Title
Measurements
OG00061.2± 179.9
OG001283.4± 218.0
OG002114.2± 163.6
OG003
Secondary
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng*min/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00044
OG00137
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.2± 9.4
OG0017.6± 10.3
OG002-5.5± 8.7
OG003
Secondary
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng*min/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00039
OG00126
OG00246
OG003
Title
Denominators
Categories
Title
Measurements
OG000-8.1± 11.5
OG0014.8± 14.0
OG002-1.6± 10.5
OG003
Secondary
Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00043
OG00135
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG000-15.24± 5.22
OG001-16.53± 5.75
OG002-16.78± 4.72
OG003
Secondary
Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00043
OG00134
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG000-23.45± 6.09
OG001-29.31± 6.80
OG002-25.32± 5.52
OG003
Secondary
Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00043
OG00133
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG000-28.45± 6.85
OG001-39.99± 7.80
OG002-27.51± 6.21
OG003
Secondary
Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00130
OG00249
OG003
Title
Denominators
Categories
Title
Measurements
OG000-14.89± 4.78
OG001-16.45± 5.58
OG002-19.57± 4.35
OG003
Secondary
Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00130
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG000-19.79± 5.35
OG001-24.04± 6.21
OG002-28.59± 4.92
OG003
Secondary
Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00130
OG00249
OG003
Title
Denominators
Categories
Title
Measurements
OG000-24.42± 6.73
OG001-35.30± 7.84
OG002-41.04± 6.14
OG003
Secondary
Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00046
OG00138
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.36± 2.74
OG0012.22± 3.02
OG0022.47± 2.53
OG003
Secondary
Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00047
OG00137
OG00253
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.20± 3.39
OG0018.51± 3.81
OG0022.04± 3.18
OG003
Secondary
Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00046
OG00137
OG00253
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.35± 4.06
OG0014.45± 4.49
OG0020.25± 3.73
OG003
Secondary
Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.93± 3.67
OG0015.79± 4.49
OG0022.87± 3.37
OG003
Secondary
Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.98± 4.09
OG00110.71± 5.01
OG0022.48± 3.79
OG003
Secondary
Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.62± 4.36
OG0014.61± 5.31
OG0020.38± 3.95
OG003
Secondary
Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00046
OG00138
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.03± 0.17
OG001-0.09± 0.19
OG002-0.12± 0.16
OG003
Secondary
Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00047
OG00137
OG00253
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.13± 0.20
OG0010.16± 0.23
OG002-0.01± 0.19
OG003
Secondary
Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00046
OG00137
OG00253
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.06± 0.22
OG0010.36± 0.25
OG002-0.16± 0.21
OG003
Secondary
Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.02± 0.23
OG0010.11± 0.28
OG002-0.12± 0.21
OG003
Secondary
Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.17± 0.23
OG0010.27± 0.29
OG0020.05± 0.22
OG003
Secondary
Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.08± 0.26
OG0010.18± 0.31
OG002-0.02± 0.23
OG003
Secondary
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00048
OG00139
OG00256
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.42± 2.54
OG001-5.23± 2.82
OG002-1.15± 2.36
OG003
Secondary
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00048
OG00138
OG00255
OG003
Title
Denominators
Categories
Title
Measurements
OG000-7.39± 3.24
OG001-15.91± 3.64
OG002-6.92± 3.05
OG003
Secondary
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00048
OG00137
OG00255
OG003
Title
Denominators
Categories
Title
Measurements
OG000-10.08± 4.01
OG001-23.94± 4.57
OG002-12.94± 3.75
OG003
Secondary
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00130
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.20± 2.68
OG0010.02± 3.13
OG0021.63± 2.47
OG003
Secondary
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00130
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.99± 3.26
OG001-5.24± 3.82
OG002-5.69± 3.06
OG003
Secondary
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00130
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG000-9.29± 4.26
OG001-16.51± 5.01
OG002-19.44± 3.94
OG003
Secondary
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00045
OG00138
OG00253
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.58± 2.53
OG001-1.04± 2.75
OG0022.85± 2.32
OG003
Secondary
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00046
OG00137
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.95± 3.25
OG0015.07± 3.61
OG0022.40± 3.05
OG003
Secondary
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00045
OG00137
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.03± 3.93
OG0011.84± 4.29
OG0020.75± 3.60
OG003
Secondary
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.33± 3.08
OG0015.26± 3.76
OG0021.98± 2.85
OG003
Secondary
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00246
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.23± 3.47
OG00110.17± 4.25
OG0021.43± 3.25
OG003
Secondary
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
uU/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.71± 3.97
OG0014.85± 4.82
OG002-0.83± 3.63
OG003
Secondary
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00045
OG00138
OG00253
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.29± 0.14
OG001-0.08± 0.16
OG0020.10± 0.13
OG003
Secondary
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00046
OG00137
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.35± 0.18
OG0010.11± 0.20
OG0020.23± 0.17
OG003
Secondary
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00045
OG00137
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.27± 0.20
OG0010.35± 0.22
OG0020.17± 0.19
OG003
Secondary
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.23± 0.16
OG0010.42± 0.20
OG0020.02± 0.15
OG003
Secondary
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00246
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.05± 0.20
OG0010.58± 0.24
OG0020.16± 0.18
OG003
Secondary
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
ng/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00041
OG00127
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.29± 0.22
OG0010.59± 0.27
OG0020.16± 0.20
OG003
Secondary
Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
pg/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00043
OG00130
OG00246
OG003
Title
Denominators
Categories
Title
Measurements
OG000-11.84± 4.11
OG001-10.92± 4.93
OG002-11.26± 3.99
OG003
Secondary
Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
pg/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00040
OG00122
OG00237
OG003
Title
Denominators
Categories
Title
Measurements
OG000-8.39± 4.12
OG001-6.06± 5.57
OG002-12.64± 4.30
OG003
Secondary
Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mEg/L
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00037
OG00135
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.01± 0.03
OG001-0.03± 0.03
OG002-0.07± 0.02
OG003
Secondary
Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mEg/L
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00032
OG00126
OG00244
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.01± 0.03
OG001-0.00± 0.03
OG002-0.06± 0.03
OG003
Secondary
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
pg/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00043
OG00129
OG00244
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.94± 3.64
OG001-5.75± 4.42
OG002-10.39± 3.60
OG003
Secondary
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
pg/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00039
OG00121
OG00236
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.96± 3.29
OG001-4.46± 4.47
OG002-6.80± 3.42
OG003
Secondary
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mEq/mL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00034
OG00130
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.02± 0.02
OG0010.01± 0.02
OG002-0.02± 0.02
OG003
Secondary
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Error
mEq/mL
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00032
OG00121
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.01± 0.02
OG001-0.04± 0.03
OG0020.02± 0.02
OG003
Secondary
Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00034
OG00120
OG00241
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.38± 2.04
OG001-0.31± 2.41
OG0020.45± 1.88
OG003
Secondary
Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00028
OG00116
OG00235
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.50± 2.03
OG001-0.19± 1.77
OG002-0.13± 1.91
OG003
Secondary
Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.
Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00034
OG00120
OG00241
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.44± 1.06
OG0010.37± 0.76
OG0020.31± 0.77
OG003
Secondary
Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00028
OG00116
OG00235
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.15± 0.99
OG0010.84± 2.31
OG0020.35± 0.97
OG003
Secondary
Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00044
OG00136
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.36± 1.36
OG0010.31± 1.27
OG002-0.04± 2.84
OG003
Secondary
Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00040
OG00126
OG00245
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.48± 2.81
OG0010.34± 1.21
OG0020.27± 3.90
OG003
Secondary
Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).
Posted
Mean
Standard Deviation
percentage of glycated hemoglobins
Baseline, Week 14
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00047
OG00139
OG00255
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.55± 0.93
OG001-0.84± 1.04
OG002-0.78± 0.98
OG003
Secondary
Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)
Posted
Mean
Standard Deviation
percentage of glycated hemoglobins
Baseline, Week 10, Week 16
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00047
OG00140
OG00256
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.34± 0.98
OG001-0.72± 0.96
OG002-0.64± 0.99
OG003
Secondary
Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).
Posted
Mean
Standard Deviation
mg/dL
Baseline, Week 8, Week 14
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00046
OG00139
OG00255
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.93± 36.86
OG001-14.03± 34.62
OG002-7.58± 29.35
OG003
Secondary
Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)
Posted
Mean
Standard Deviation
mg/dL
Baseline, Week 10, Week 16
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00045
OG00140
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.82± 31.60
OG001-11.55± 33.73
OG002-6.65± 46.36
OG003
Secondary
Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 14 or Week 8, participants must have had a baseline and at least 1 post-baseline measurement. The Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).
Posted
Mean
Standard Deviation
umol/L
Baseline, Week 8, Week 14
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00047
OG00140
OG00256
OG003
Title
Denominators
Categories
Title
Measurements
OG000-12.40± 35.18
OG001-19.78± 33.80
OG002-12.77± 37.92
OG003
Secondary
Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)
Posted
Mean
Standard Deviation
umol/L
Baseline, Week 10, Week 16
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00047
OG00141
OG00255
OG003
Title
Denominators
Categories
Title
Measurements
OG000-8.60± 39.61
OG001-8.02± 37.54
OG002-11.02± 40.73
OG003
Secondary
Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C <7%, ≥7% to <8%, ≥8% to <9%, and ≥9% in the 0 & 100 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Deviation
percent
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG001
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00043
OG00135
Title
Denominators
Categories
<7% (n=8; n=12)
Title
Measurements
OG000-0.61± 0.26
OG001-0.18± 0.27
≥7% to <8% (n=20; n=8)
Title
Measurements
OG000
Secondary
Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG <140 mg/dL, ≥140 mg/dL to <180 mg/dL, and ≥ 180 mg/dL in the 0 & 100 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Deviation
mg/dL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG001
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00043
OG00137
Title
Denominators
Categories
< 140 mg/dL (n=17; n=17)
Title
Measurements
OG000-11.12± 12.51
OG0011.29± 12.95
140 - < 180 mg/dL (n=17; n=14)
Title
Measurements
OG000
Secondary
Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort
Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose <140 mg/dL, ≥140 to <200 mg/dL, and ≥200 mg/dL in the 0 & 100 mg cohort.
Randomized participants. To be included in analysis of change from baseline to Week 6, participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Mean
Standard Deviation
mg/dL
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG001
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00038
OG00135
Title
Denominators
Categories
<140 mg/dL (n=1; n=3)
Title
Measurements
OG000-18.00± 0.00
OG00111.33± 12.10
≥140 to <200 mg/dL (n=17; n=12)
Title
Measurements
OG000
Secondary
Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort
Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort.
Randomized participants. To be included in the Week 6 LOCF analysis, subjects must have had at least 1 post-baseline measurement.
Posted
Number
Percentage of Participants
Week 6
ID
Title
Description
OG000
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG001
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00044
OG00141
Title
Denominators
Categories
Title
Measurements
OG00072
OG00149
Secondary
Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort
Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)
Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Posted
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG001
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG0000
OG0010
Secondary
Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort
Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)
Posted
Baseline, Week 6
ID
Title
Description
OG000
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG001
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG0000
OG0010
Secondary
Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control
Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.)
Posted
Week 4, Week 6
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
OG006
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG007
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
All participants randomized and treated during the double-blind period.
Posted
Number
Percentage of participants
up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00055
OG00147
OG00263
OG003
Title
Denominators
Categories
At least one AE
Title
Measurements
OG00080.0
OG00176.6
OG00277.8
OG003
Secondary
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
All participants randomized and treated during the double-blind period.
Posted
Number
Percentage of participants
up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations
ID
Title
Description
OG000
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG001
Placebo (0 & 100 Cohort)
Units
Counts
Participants
OG00044
OG00141
Title
Denominators
Categories
At least one AE
Title
Measurements
OG00065.9
OG00158.5
At least one SAE
Title
Measurements
OG000
Secondary
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
All participants treated during the follow-up period.
Posted
Number
Percentage of participants
From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations
ID
Title
Description
OG000
Saxagliptin 2.5 mg (0-40 mg Cohort)
OG001
Saxagliptin 5 mg (0-40 mg Cohort)
OG002
Saxagliptin 10 mg (0-40 mg Cohort)
OG003
Saxagliptin 20 mg (0-40 mg Cohort)
OG004
Saxagliptin 40 mg (0-40 mg Cohort)
OG005
Placebo (0-40 mg Cohort)
Units
Counts
Participants
OG00050
OG00142
OG00258
OG003
Title
Denominators
Categories
At least one AE
Title
Measurements
OG00034.0
OG00142.9
OG00237.9
OG003
Secondary
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
All participants treated during the follow-up period.
Posted
Number
Percentage of participants
From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations
ID
Title
Description
OG000
Saxagliptin 100 mg (0 & 100 mg Cohort)
OG001
Placebo (0 & 100 mg Cohort)
Units
Counts
Participants
OG00044
OG00136
Title
Denominators
Categories
At least one AE
Title
Measurements
OG00031.8
OG00133.3
At least one SAE
Title
Measurements
OG000
1
63
36
63
EG001
Saxagliptin 100 mg (0 & 100 mg Cohort)
The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
0
44
16
44
EG002
Saxagliptin 2.5 mg (0-40 mg Cohort)
The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
1
55
35
55
EG003
Saxagliptin 20 mg (0-40 mg Cohort)
The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
2
54
33
54
EG004
Saxagliptin 40 mg (0-40 mg Cohort)
The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
0
52
27
52
EG005
Saxagliptin 5 mg (0-40 mg Cohort)
The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
0
47
23
47
EG006
Placebo (0 & 100 mg Cohort)
The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
0
41
17
41
EG007
Placebo (0-40 mg Cohort)
The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
2
67
38
67
EG0000 affected63 at risk
EG0010 affected44 at risk
EG0020 affected55 at risk
EG0031 affected54 at risk
EG0040 affected52 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected67 at risk
Umbilical Hernia
Gastrointestinal disorders
MedDRA 7
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected44 at risk
EG0020 affected55 at risk
EG0030 affected54 at risk
EG0040 affected52 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected67 at risk
Pneumonia
Infections and infestations
MedDRA 7
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected44 at risk
EG0021 affected55 at risk
EG0030 affected54 at risk
EG0040 affected52 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected67 at risk
Appendicitis
Infections and infestations
MedDRA 7
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected44 at risk
EG0020 affected55 at risk
EG0030 affected54 at risk
EG0040 affected52 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected67 at risk
Gastroenteritis
Infections and infestations
MedDRA 7
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected44 at risk
EG0020 affected55 at risk
EG0031 affected54 at risk
EG0040 affected52 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected67 at risk
Urinary Tract Infection
Infections and infestations
MedDRA 7
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected44 at risk
EG0020 affected55 at risk
EG0030 affected54 at risk
EG0040 affected52 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected67 at risk
Cystocele
Renal and urinary disorders
MedDRA 7
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected44 at risk
EG0020 affected55 at risk
EG0031 affected54 at risk
EG0040 affected52 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected67 at risk
EG0000 affected63 at risk
EG0010 affected44 at risk
EG0020 affected55 at risk
EG0030 affected54 at risk
EG0040 affected52 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0074 affected67 at risk
Blood Creatine Phosphokinase Increased
Investigations
MedDRA 7
Systematic Assessment
EG0000 affected63 at risk
EG0011 affected44 at risk
EG0021 affected55 at risk
EG0032 affected54 at risk
EG0042 affected52 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0071 affected67 at risk
Hot Flush
Vascular disorders
MedDRA 7
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected44 at risk
EG0023 affected55 at risk
EG0030 affected54 at risk
EG0041 affected52 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected67 at risk
Headache
Nervous system disorders
MedDRA 7
Systematic Assessment
EG00010 affected63 at risk
EG0015 affected44 at risk
EG0028 affected55 at risk
EG0036 affected54 at risk
EG0045 affected52 at risk
EG0054 affected47 at risk
EG0062 affected41 at risk
EG0076 affected67 at risk
Nausea
Gastrointestinal disorders
MedDRA 7
Systematic Assessment
EG0002 affected63 at risk
EG0010 affected44 at risk
EG0021 affected55 at risk
EG0032 affected54 at risk
EG0045 affected52 at risk
EG0052 affected47 at risk
EG0062 affected41 at risk
EG0075 affected67 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 7
Systematic Assessment
EG0002 affected63 at risk
EG0012 affected44 at risk
EG0023 affected55 at risk
EG0030 affected54 at risk
EG0041 affected52 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0074 affected67 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 7
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected44 at risk
EG0020 affected55 at risk
EG0034 affected54 at risk
EG0041 affected52 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0070 affected67 at risk
Constipation
Gastrointestinal disorders
MedDRA 7
Systematic Assessment
EG0003 affected63 at risk
EG0013 affected44 at risk
EG0023 affected55 at risk
EG0033 affected54 at risk
EG0043 affected52 at risk
EG0050 affected47 at risk
EG0062 affected41 at risk
EG0072 affected67 at risk
Influenza
Infections and infestations
MedDRA 7
Systematic Assessment
EG0002 affected63 at risk
EG0010 affected44 at risk
EG0023 affected55 at risk
EG0031 affected54 at risk
EG0042 affected52 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0073 affected67 at risk
Sinusitis
Infections and infestations
MedDRA 7
Systematic Assessment
EG0004 affected63 at risk
EG0012 affected44 at risk
EG0022 affected55 at risk
EG0031 affected54 at risk
EG0041 affected52 at risk
EG0052 affected47 at risk
EG0062 affected41 at risk
EG0074 affected67 at risk
Bronchitis
Infections and infestations
MedDRA 7
Systematic Assessment
EG0002 affected63 at risk
EG0010 affected44 at risk
EG0021 affected55 at risk
EG0031 affected54 at risk
EG0041 affected52 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0074 affected67 at risk
Nasopharyngitis
Infections and infestations
MedDRA 7
Systematic Assessment
EG0005 affected63 at risk
EG0011 affected44 at risk
EG0020 affected55 at risk
EG0033 affected54 at risk
EG0046 affected52 at risk
EG0052 affected47 at risk
EG0061 affected41 at risk
EG0075 affected67 at risk
Urinary Tract Infection
Infections and infestations
MedDRA 7
Systematic Assessment
EG0004 affected63 at risk
EG0014 affected44 at risk
EG0026 affected55 at risk
EG0035 affected54 at risk
EG0042 affected52 at risk
EG0052 affected47 at risk
EG0062 affected41 at risk
EG0075 affected67 at risk
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 7
Systematic Assessment
EG0006 affected63 at risk
EG0010 affected44 at risk
EG0026 affected55 at risk
EG0036 affected54 at risk
EG0040 affected52 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0074 affected67 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 7
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected44 at risk
EG0023 affected55 at risk
EG0031 affected54 at risk
EG0042 affected52 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0071 affected67 at risk
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 7
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected44 at risk
EG0023 affected55 at risk
EG0034 affected54 at risk
EG0041 affected52 at risk
EG0052 affected47 at risk
EG0060 affected41 at risk
EG0073 affected67 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 7
Systematic Assessment
EG0003 affected63 at risk
EG0011 affected44 at risk
EG0026 affected55 at risk
EG0035 affected54 at risk
EG0042 affected52 at risk
EG0053 affected47 at risk
EG0061 affected41 at risk
EG0072 affected67 at risk
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA 7
Systematic Assessment
EG0002 affected63 at risk
EG0010 affected44 at risk
EG0023 affected55 at risk
EG0032 affected54 at risk
EG0043 affected52 at risk
EG0052 affected47 at risk
EG0061 affected41 at risk
EG0073 affected67 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 7
Systematic Assessment
EG0001 affected63 at risk
EG0012 affected44 at risk
EG0024 affected55 at risk
EG0033 affected54 at risk
EG0043 affected52 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0073 affected67 at risk
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 7
Systematic Assessment
EG0003 affected63 at risk
EG0012 affected44 at risk
EG0021 affected55 at risk
EG0030 affected54 at risk
EG0041 affected52 at risk
EG0053 affected47 at risk
EG0061 affected41 at risk
EG0072 affected67 at risk
Pharyngolaryngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 7
Systematic Assessment
EG0000 affected63 at risk
EG0011 affected44 at risk
EG0022 affected55 at risk
EG0031 affected54 at risk
EG0042 affected52 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0074 affected67 at risk
Fatigue
General disorders
MedDRA 7
Systematic Assessment
EG0001 affected63 at risk
EG0013 affected44 at risk
EG0022 affected55 at risk
EG0032 affected54 at risk
EG0043 affected52 at risk
EG0050 affected47 at risk
EG0062 affected41 at risk
EG0070 affected67 at risk
Oedema Peripheral
General disorders
MedDRA 7
Systematic Assessment
EG0004 affected63 at risk
EG0012 affected44 at risk
EG0020 affected55 at risk
EG0031 affected54 at risk
EG0042 affected52 at risk
EG0051 affected47 at risk
EG0061 affected41 at risk
EG0078 affected67 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.